1. Field of the Invention
The present invention relates to packages for flat, pliable objects, especially for film-shaped or wafer-shaped drug forms. These are non-reclosable packages the contents of which become accessible upon opening the package by peeling off a cover layer (e.g. peel film), and opening of which does not necessitate the use of auxiliary means, especially tools (scissors, knives etc.). The packages according to the invention possess features which prevent unauthorized opening, especially by children, or at least render unauthorised opening more difficult. The invention further relates to the use of such packages for packaging flat, pliable objects, as well as processes for packaging such objects by means of the said packages.
2. Description of the Prior Art
Apart from the known administration forms for medicaments, such as tablets, capsules etc., so-called “wafers” are also used for the administration of medicaments, especially for oral administration thereof. These are small, thin plates made of an active substance-containing film and whose thickness and dimensions are adapted to the amount of active substance to be released. A wafer is generally flexible, soft, of low weight, and tearable. The overall thickness of such a film-shaped medicament may be 5 μm to 5 mm, usually 50 μm to 1 mm. The shape of its surface may be round, oval, triangular or quadrangular, or polygonal, or it may be of any rounded shape. Suitable active substances are medicinal agents of all classes, for example analgesics, psychopharmacologic agents, or even nicotine for smoking cessation.
Because of the active substance content of the wafers, it is indispensable to package them in such a way that they cannot be removed and taken or swallowed by unauthorized persons, especially by children. At least, the process of opening the package should be made more difficult or delayed.
Child-resistant packages are known above all in the field of blister packages for tablets. For example, opening such a package can be made more difficult by providing the lid layer of the blister package with a peel layer which prevents the tablet from being pushed through the lid layer, and thereby prevents removal of the tablet. Only after having peeled off the peel layer is it possible to remove the tablet in the usual manner, by pushing it through the lid layer (DE 196 13 959 A1). Such packages are, however, not suitable for packaging thin, flexible drug forms (e.g. wafers) since, due to their physical characteristics, wafers cannot be removed from a package by pushing them through the package.
DE 197 43 485 A1 describes a child-resistant package for products that have a large area and are sensitive to pressure, e.g. transdermal therapeutic systems. The package is made of a dimensionally stable carrier sheet and a peelable, flexible cover layer; the two sheets are sealed to one another. The carrier sheet is provided with a perforation which can be broken open by bending. On breaking open the perforation, a broken edge is formed which serves as a gripping aid for peeling off the cover layer. Unauthorised opening by children is prevented by the fact that the rigidity of the sheets sealed to one another is such that children are not able to summon up the strength in their fingers which is required to bend open the break-open aid, while adults are able to do so.
A disadvantage of this package is that opening of the package is possible without hindrance once the first obstacle—bending open—has been overcome. The resultant gripping aid even facilitates peeling away the cover layer.